Study of Olutasidenib and Temozolomide in HGG

Study Summary

The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.

Conditions

High Grade Glioma Astrocytoma Astrocytoma, Grade III Astrocytoma, Grade IV Diffuse Intrinsic Pontine Glioma WHO Grade III Glioma WHO Grade IV Glioma Metastatic Brain Tumor Diffuse Midline Glioma, H3 K27M-Mutant Thalamus Tumor Spinal Tumor IDH1 Mutation IDH1 R132 IDH1 R132C IDH1 R132H IDH1 R132S IDH1 R132G IDH1 R132L Oligodendroglioma

Interventions / Drugs

Olutasidenib + TMZ

View on ClinicalTrials.gov ↗

Sponsor

RIGL

Rigel Pharmaceuticals

Immunology

D39/100

Study Details

Enrollment60 participants

Primary Completion—

Lead SponsorRigel Pharmaceuticals

Data Retrieved2026-04-11 04:25:58.320513+00:00

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